ProPharma
5001 - 10000 employees
Founded 2001
🏥 Healthcare
📦 Logistics
🏭 Manufacturing
💰 $8.6M Venture Round on 2020-10
Healthcare • Logistics • Manufacturing
ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.
Associate Director – Auditor, Computer System Validation, AI Assurance, Data Integrity
🔥 0 minutes ago
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ProPharma
5001 - 10000 employees
Founded 2001
🏥 Healthcare
📦 Logistics
🏭 Manufacturing
💰 $8.6M Venture Round on 2020-10
Healthcare • Logistics • Manufacturing
ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.
📋 Description
• Conduct audits of pharmaceutical, medical device, clinical, and software development organizations for compliance with regulations applicable to computer systems, artificial intelligence, and data integrity • Conduct gap assessments and provide remediation guidance • Author policies, procedures, and work instructions • Advise clients on computer system validation, AI compliance, and data integrity approaches • Manage internal resources executing client strategies • Develop and maintain internal procedures and tools for CSV, AI assurance, and data integrity services • Develop and deliver original content including blogs, training materials, and webinars • Teach computer system validation, software/AI quality compliance, and data integrity classes • Participate in business strategies for growth of the CSV, AI Assurance, and Data Integrity practice • Assist with marketing and sales materials • Assist with business development activities • Assist Operations in staffing client projects • Lead interviews of ProPharma candidates • Travel as required • Perform other duties as assigned
🎯 Requirements
• BSc or higher in a life-sciences or related discipline • Certified auditor • Minimum 10 years of auditing experience • At least 30 audits in CSV, IT GxP compliance, AI GxP compliance, or electronic data integrity • Minimum 15 years in the pharmaceutical or medical device industry • Fluent in English; ideally fluent in another EU language • Experience validating automation control, laboratory, quality management, ERP, clinical trial, and pharmacovigilance systems • Experience validating SaaS, PaaS, IaaS, and on-premises delivery models • Basic understanding of AI use cases and emerging GxP compliance requirements • Experience authoring policies and procedures/SOPs • Experience conducting audits and gap assessments • Experience managing internal personnel, contract resources, and projects • Expert knowledge of FDA 21 CFR 11 and EU Annex 11 • Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting ICH and PIC/S documents • Expert knowledge of GAMP5, ANSI S-95 and S-88, and ASTM E2500 • Expert knowledge of data integrity guidance from the US FDA, EMA, MHRA, PIC/S, and WHO • Proficiency in public speaking in in-person and online forums • Some travel required
🏖️ Benefits
• Remote working support • Hybrid working encouraged for new hires near an office • Equal Opportunity Employer workplace • Diversity, equity, and inclusion commitment • Safe and empowering workplace • Applications personally reviewed by recruitment team • Outcome communicated for every application
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